Replies to post #417148 on Anavex Life Sciences Corp (AVXL)

[Joseph_K]

I wish I hadn't included my side comment about not terribly important. (I agree with both your and Investor's replies, even if that sounds contradictory, and had those thoughts before writing the post.) I was just wondering how people regarded Missling's comment, if they think it shows a PM is now most likely. (Investor, no need for you to weigh in on this one; since for you it's just confirmation of an already strong viewpoint.)

[Investor2014]

Yes, and we need to accept that traditional approval as a P3 trial now appears off the table.

The only thing that really matters now is an FDA approval, provisional or final, for AD based on an NDA for the 2b/3 trial.

Thus for early revenue everything now relies on presenting surrogate biomarkers acceptable for Accelerated Approval (AA) and a sufficient number of patients with correlated meaningful clinical outcomes.

The worst that could happen short term is that AA is not granted, but we have a Precision Medicine P3 trial well underway likely to gain approval in AD some 3 - 4 years from now. Of course with some risk of new competitors succeeding in increasing the Stand of Care (SOC) barrier.